WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS (SEE WARNINGS).
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS. FATAL LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION OF DIDANOSINE AND STAVUDINE WITH OTHER ANTIRETROVIRAL AGENTS. THE COMBINATION OF DIDANOSINE AND STAVUDINE SHOULD BE USED WITH CAUTION DURING PREGNANCY AND IS RECOMMENDED ONLY IF THE POTENTIAL BENEFIT CLEARLY OUTWEIGHS THE POTENTIAL RISK (SEE WARNINGS AND PRECAUTIONS: PREGNANCY, REPRODUCTION, AND FERTILITY).
|
NEWS HIGHLIGHTS
Published Studies Related to Videx (Didanosine)
Response to zidovudine/didanosine-containing combination antiretroviral therapy among HIV-1 subtype C-infected adults in Botswana: two-year outcomes from a randomized clinical trial. [2009.05.01]
BACKGROUND: Numerous national antiretroviral (ARV) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy (cART) have recently commenced in southern Africa, the first of which began in Botswana in January 2002. Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region, as does investigation of the development of drug resistance and the optimal means of sustaining adherence. The "Tshepo" Study is the first large-scale, randomized, clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa... CONCLUSIONS: The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults. ZDV/ddI-containing cART, however, is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART.
Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. [2008.10.15]
BACKGROUND: The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed in clinical trials... CONCLUSIONS: At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. CLINICAL TRIALS REGISTRATION: NCT00256828.
Low-level K65R mutation in HIV-1 reverse transcriptase of treatment-experienced patients exposed to abacavir or didanosine. [2007.10.01]
BACKGROUND: Prior abacavir (ABC) or didanosine (ddI) therapy can result in the L74V/I or K65R mutation in HIV-1 reverse transcriptase. Preexisting K65R may have an impact on the treatment response to tenofovir disoproxil fumarate (TDF)... CONCLUSIONS: Prior therapy with ABC or ddI can result in a population genotype that shows K65R or L74V/I but does not reveal low-level K65R present in some patients. Subsequent treatment intensification with TDF resulted in a poor virologic response and may result in expansion of the preexisting K65R mutant.
Stavudine but not didanosine as part of HAART contributes to peripheral lipoatrophy: a substudy from the Antiretroviral Regimen Evaluation Study (ARES). [2007.09]
CONCLUSION: This study suggests that didanosine/lamivudine, when combined with either nevirapine or ritonavir-boosted saquinavir over 96 weeks of therapy, is possibly not associated with limb fat atrophy, in contrast to when treatment contained didanosine, stavudine, and nelfinavir combined.
Baseline genotype as a predictor of virological failure to emtricitabine or stavudine in combination with didanosine and efavirenz. [2007.08]
The presence of drug-associated mutations among ART-naive, HIV-1(+) patients may compromise the response to antiviral therapy. We evaluated the effect of preexisting drug-associated resistance mutations to the response in treatment-naive patients to therapy with emtricitabine (FTC) or stavudine (d4T) in combination with didanosine (ddI) and efavirenz (EFV)...
Clinical Trials Related to Videx (Didanosine)
Bioequivalence Study of Didanosine in Children Treated for HIV [Not yet recruiting]
The purpose of this study is to show that the administration of 400/mg/m2/day of
didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of
didanosine during fasting, in HIV infected children treated by a ARV combination including
ddI
Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV co-Infected Patients [Recruiting]
The primary purpose of this study is to evaluate the impact of changing didanosine in an
effective anti-HIV regimen to tenofovir on virologic suppression. We hypothesize that, in
patients with maximal virologic suppression on a double class regimen (including two NRTIs
and an NNRTI or a PI, boosted with RTV or not), a single drug substitution of didanosine for
tenofovir will represent a viable strategy without any negative impact on the virologic
efficacy of the regimen.
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth [Recruiting]
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given
to HIV infected pregnant women during and after their pregnancies is most effective in
reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and
lopinavir/ritonavir (LPV/r) will also be studied.
Study hypothesis: NVP resistance following single-dose NVP can be prevented with the
concomitant administration of additional antiretroviral therapy (ART).
Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-Tuberculosis Treatment [Recruiting]
Protocol Summary
Title: Evaluation of safety and efficacy of two different once daily anti-retroviral
treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and
tuberculosis - Randomized Controlled Clinical Trial
Phase: Phase III trial
Population: 180 HIV-1 positive patients with tuberculosis
Number of Sites: Four.
1. Tuberculosis Research Centre, Chennai
2. Government Medical College, Vellore
3. Government Hospital of Thoracic Medicine, Tambaram
4. Government Rajaji Hospital, Madurai
Study Duration: 26 months including 24 months of ART.
Study Objectives:
Primary Objective To compare the efficacy and safety of two different once-daily
anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in
patients with HIV-1 and tuberculosis, by using virologic end points.
Secondary Objective To compare the efficacy of antiretroviral treatment given under partial
supervision with unsupervised treatment (once a month supply).
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children [Recruiting]
The primary purpose of this study is to find the dose of Efavirenz for young children. The
safety and how the medication is tolerated will also be studied.
|
